A 4-Day, Randomized, Controlled, Open Application Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers, Using a Phototoxicity Test Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.
Jonothan S Dosik, MD
United States: Food and Drug Administration
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